newsletter october , 2018iec 80601-2-59:2017 iso 80601-2-61:2017 iec 60601-2-63:2012+a1:2017 iec...

Address :3611, Hagun-ri, Yangchon-eup, Gimpo-si,Gyeonggi-do , South Korea (10048)

Company Id No : 110111-243147Tax & VAT Id No : 105-86-35114

Tel : (+82)2-6351-9001~5 / Fax : (+82)2-6351-9007Home page : www.icrqa.com

NewsletterOctober, 2018




Hot Issue

1. RRA Completion

2. Expanded standards for KOLAS Medical device field

3. IEC / EN 62368-1 KOLAS Audit

4. Application of safety verification testing agency

5. HKMC EMC Technology council meeting

6. Wonju medical high school visiting ICR

7. ISO 19011:2018 Revision

8. OFFSHORE KOREA 2018

9. CSA Group Field Evaluation Seminar

10. CSA Group Cybersecurity Seminar




RRA Completion (Electromagnetic Test Headquarters)

On September 17, 2018 at the RRA 5G mobile communication

Additional Designated.

ICR Co., Ltd. has developed a For all electrical / electronic products

in the industrial sector KC test certification / registration is

provided. Thank you for your interest.




Expanded standards for KOLAS Medical device field

In order to provide safer and more

accurate testing and certification services

to our customers,

ICR conducted field assessments to

standards change and update for KOLAS

medical devices field.

In addition, the latest standards will be

applied to standards recognized as CBTL

by IECEE.

We promise to provide you with a better

level of testing in the future.




Expanded standards for KOLAS Medical device field

KOLASIEC 60601-2-2:2017

IEC 60601-2-4:2010+A1:2018

IEC 60601-2-28:2017

IEC 80601-2-30:2018

IEC 60601-2-43:2010+A1:2017

IEC 80601-2-49:2018

IEC 60601-2-54:2009+A1:2015+A2:2018

IEC 80601-2-59:2017

ISO 80601-2-61:2017

IEC 60601-2-63:2012+A1:2017

IEC 60601-2-65:2012+A1:2017

CBTL

IEC 60601-2-4:2010+A1:2018

IEC 80601-2-30:2018

IEC 80601-2-49:2018

IEC 60601-2-54:2009+A1:2015+A2:2018

ISO 80601-2-61:2017

IEC 60601-2-63:2012+A1:2017

IEC 60601-2-65:2012+A1:2017




KOLAS is a Korean stabiliser and KOLAS recognition system

Supports industrial activities through recognition system that

can be used in various fields in domestic industry.

In large part, the company operates a system of

accreditation by Calibration institutions, testing agencies,

testing agencies, reference materials production agencies,

medical testing institutions, and proficiency testing

management institutions.

For 3 days from September 17 to 19, KOLAS was

extended/renewed.

This time, the Electrical & Electronics testing team has

extended the IEC / EN 62368-1 standard, completed the

audit without any problems and will serve.

IEC / EN 62368-1 KOLAS Audit




Application of safety verification testing agency

We have completed the application of the safety

verification testing agency on September 4 and will

be available as early as this year.




HKMC EMC Technology council meeting

HKMC 3rd 2018 EMC technology council meeting in ICR at 20th Sep 2018.




Subject

� Wireless changing system and EMC

considerations

� High voltage system and EMC considerations

for commercial vehicles

� ICR lab tour

� EMC technology trend of ADAS

� HKMC test plan

HKMC EMC Technology council meeting




Wonju Medical Equipment Technology High school visiting ICRfor education

From September 27th to 28th, we conducted an ICR tour

at Wonju Medical Equipment Technology High school,

which is a mecca for training medical professionals.

Wonju Medical Equipment Technology High school is the

only Mister High School in Korea in the medical equipment

field, and it is a school that boasts excellent education as

well as fostering the medical device industry.




Through this tour, we have provided students with

detailed explanations on medical device certification

and the IEC 60601-1 standard, which is a common

standard for medical devices, as well as providing

lectures on system certification and product

certification.





In this tour, the actual students

were not only trained in

specification theory, but also

conducted electrical safety

tests based on the common

standard of IEC 60601-1.

Through power input, leakage

current, and ground continuity

test, it was a good opportunity

for students to realize the

importance and methods of

testing carried out in an actual

laboratory.





The ICR was also meaningful as I met students of

Wonju Medical Equipment Technology High school,

who are excellent human resources based on

various curricula and expertise of medical

equipment development.

By taking this opportunity in the future, we will

become an ICR that will bring many experiences to

future students.





ISO 19011:2018 Revision

In July 2018, Guidelines for auditing management

systems, ISO 19011:2018 is revised and published.

Followings are the main changes.

– The importance of audit program is

emphasized.

– Risk-based approach is adopted throughout

the entire audit processes.

– Auditing guidance for the risk-based

thinking, context of organization, etc., which

are newly introduced by High Level Structure,

is clearly explained.




ISO 19011:2018 Requirements

3. Terms and definitions

4. Principles of auditing

5. Managing an audit programme5.1 General5.2 Establishing audit programme objectives5.3 Determining and evaluating audit programme risks and

opportunities5.4 Establishing the audit programme5.5 Implementing audit programme5.6 Monitoring audit programme5.7 Reviewing and improving audit programme

6. Conducting an audit6.1 General6.2 Initiating audit6.3 Preparing audit activities6.4 Conducting audit activities6.5 Preparing and distributing audit report6.6 Completing audit6.7 Conducting audit follow-up

7. Competence and evaluation of auditors7.1 General7.2 Determining auditor competence7.3 Establishing auditor evaluating criteria7.4 Selecting appropriate auditor evaluation method7.5 Conducting auditor evaluation7.6 Maintaining and improving auditor competence

ISO 19011:2018 Revision




OFFSHORE KOREA 2018

ICR has been designated as ATEX, ISO 45001,Korean Register of Shipping (KR) approvaltesting institute.

ICR will participate in OFFSHORE KOREA 2018 toprovide various services and promote.

The exhibition will be held at Busan, BEXCO's 1stexhibition hall from October 10 to October 12,2018.




If you register in advance, you will be free to enter the exhibition hall without a separate registration procedure.

Pre-registration: https://www.okkorea.org

OFFSHORE KOREA 2018




We introduce exhibitors with OFFSHORE KOREA 2018

OFFSHORE KOREA 2018




Ocean Plant Technology Conference(OK Conference 2018)

OFFSHORE KOREA 2018




Busan, BEXCO 1st exhibition hall will be held.

Thank you for your interest and participation.

OFFSHORE KOREA 2018




CSA Group Field Evaluation Seminar

Product Safety Compliance in the North American Market

An Introduction to CSA Group’s North American Field

Evaluation Service

Unique circumstances sometimes make it challenging, impractical, or

even impossible for you to undergo the regular certification process.

But demonstrating your electrical product’s compliance to safety

requirements through a field evaluation (FE) may be the solution. This

one-time evaluation service is quick and efficient, and helps you get

your products into North America when you need approval from local

Authorities Having Jurisdiction (AHJ).

During this seminar, our technical experts at CSA Group will provide

an in-depth overview of U.S. and Canadian regulations, including SPE

1000 and NFPA 791, to help ensure your products are accepted by

state, provincial, and territorial authorities.




Agenda

Date: 2018. 10. 16 (TUE) 13:00~17:00 (Reception: 12:30~)

Venue: COEX Conference Room (South) 301A(513, Yeongdong-daero, Gangnamgu, Seoul )

Cost: Free

Host: CSA Group’s Korean Office

Register and Contact: Jessie Cho (CSA Group)(02-6371-6018, [email protected])

Topic

General Overview of Model Code (Canada)

Construction Details (SPE-1000)

Testing and Marking (SPE-1000)

General Overview of NFPA-791 (USA)

How to Apply Field Evaluation (FE)

Q&A

CSA Group Field Evaluation Seminar




CSA Group Cybersecurity Seminar

Navigating Regulatory Requirements for Medical Devices

Major advances in medical technologies over the last few decades have

contributed to early diagnosis of diseases, more efficient delivery of treatment,

and longer, healthier lives. Network-connected medical devices in particular are

redefining 21st century healthcare. With many life-sustaining and life-supporting

medical devices residing on hospital networks – and many more connected

wirelessly – the risk for cyber-attack is high, and this could compromise a device’s

functionality, personal information, and patients’ health and safety. Implementing

cybersecurity measures for devices and the networks to which they connect is

critical, and CSA Group’s cybersecurity services can help.

Join CSA Group’s Laura Élan, Senior Manager of Cybersecurity as she

addresses including :

• Overview of Cybersecurity Regulatory Guidance with an Emphasis on US FDA

Pre/Post Market Guidance

• Overview of Cybersecurity Frameworks and Standards to Support Medical Device

Manufactures

• Essential Activities for Medical Device Companies to Address Product

Cybersecurity

• Introduction to Security Risk Analysis for Medical Device and Software

Manufactures




Date: 2018. 10. 25 (THU) 13:30~18:00 (Reception: 13:00~)Venue: Conference B, SKY31 Convention, 31F,

Lotte World Tower (300 Olyimpic-ro, Songpa-gu, Seoul)Cost: Free

Host: CSA Group’s Korean Office Speaker: Laura Élan, P.E., RAC,

Senior Manager of Cybersecurity, CSA GroupLaura Élan recently joined CSA Group’s Innovation Team as Sr. Cybersecurity Manager to support several industry verticals including healthcare solutions. Prior to joining CSA Group, she served as the Cybersecurity Practice Lead for UL’s Digital Health Service team, supporting medical device software and solutions customers in meeting regulatory and business imperatives for software and cybersecurity assurance. Laura has more than 30 years of software and product development and compliance engineering experience, grounded in several decades of senior leadership roles with R&D and manufacturing organizations, including medical devices, and commercial and consumer electronics companies. Laura holds a BSEE from the University of Illinois, Urbana, and an MSEE from the Illinois Institute of Technology, Chicago. She is currently pursuing a graduate degree in computer science with a focus on cybersecurity. She is a licensed Professional Engineer in the State of Illinois and holds the RAC credential from the Regulatory Affairs Professionals Society.

Register and Contact: Jessie Cho (CSA Group)(02-6371-6018, [email protected])

CSA Group Cybersecurity Seminar

newsletter october , 2018iec 80601-2-59:2017 iso 80601-2-61:2017 iec 60601-2-63:2012+a1:2017 iec...

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